CompletedPhase 3

A Study to Assess the Long-term Safety and Efficacy of ASP1941 in Japanese Diabetic Patients

Japan182 participantsStarted 2010-01-14

Plain-language summary

The primary objective of this study is to evaluate the long-term safety of ASP1941 in patients with type 2 diabetes mellitus. The second objectives are to compare the efficacy and pharmacokinetics of ASP1941 administered before or after food intake.

Who can participate

Age range20 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Type 2 diabetic patients for at least 12 weeks * HbA1c value between 6.5 and 9.5% * Body Mass Index ( BMI )20.0 - 45.0kg/m2 Exclusion Criteria: * Type 1 diabetes mellitus patients * Serum creatinine \> upper limit of normal * Proteinuria (albumin/creatinine ratio \> 300mg/g) * Dysuria and/or urinary tract infection, genital infection * Significant renal, hepatic or cardiovascular diseases * Severe gastrointestinal diseases * Proliferative diabetic retinopathy

What they're measuring

HbA1c

Timeframe: For 52 weeks

Trial details

NCT IDNCT01054092

SponsorAstellas Pharma Inc

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2011-07-22

View on ClinicalTrials.gov More Type 2 Diabetes Mellitus trials